Grant Weaknesses Research Problem: Hypothesis -ill-defined, lacking, faulty,
diffuse, unwarrented.
Research Problem: Significance - unimportant, unimaginative, unlikely to provide new information.
Experimental Design: Study group or Controls - inappropriate composition, number, or characteristics.
Experimental Design: Technical Methodology -questionable, unsuited, defective.
Grant Weaknesses (cont’d) Experimental Design: Data Collection Procedures - confused
design, inappropriate instrumentation, timing or conditions.
Experimental Design: Data Management and Analysis - vague, unsophisticated, not likely to provide accurate and clearcut results.
Investigator - Inadequate expertise or familiarity with literature in the research area, poor past performance or productivity on an NIH grant, insufficient time to be devoted to project.
Resources - inadequate institutional setting, support staff, laboratory facilities, equipment or personnel, restricted access to appropriate patient population, insufficient.
GOOD IDEA Hypotheses
Significant; testable; supporting rationale
AimsFocused, test hypotheses, not overly ambitious; not superficial
Preliminary DataRationale for hypotheses; demonstrate capability; correct interpretation
General Considerationsnot merely data gathering; describe next logical steps
GOOD SCIENCE Planning
logical organization, rationale for methods selected; alternatives; controls
Detailsbrief when P.I.s methods; extensive when methods of others
Critical assessmentProblems and pitfalls; assumptions and limitations; justify level of sophistication
Statistical AspectsStatistical design/power; supportive consultant
GOOD APPLICATION Basic Considerations
read and follow all instructions; clear and lucid style; never assume reviewers “will know what you mean”; seek presubmission review by colleagues.
Administrativeobtain appropriate signatures
Duration and Budgetmoderate and realistic period; only appropriate funds to accomplish research
Justificationpersonnel: the role and percent effort; equipment: necessity and availability.
GOOD APPLICATION (cont’d) Consultants
technical advise in preparing application; supportive letter
Research Planfollow page limits and suggestions above; proper care and approvals for human subjects and vertebrate animals.
Appendixinclude appropriate supplementary data; do not include essential material
Amended Applicationassess whether amended proposal is likely to be successful; be responsive to reviewers critique; be positive; do not be vindictive and sarcastic
Good Biological and Clinical Science
A significant biological or clinical problem; describe the likelihood of altering current clinical practice.
Research based on logical, well-defined, and testable hypotheses and associated specific aims
Demonstrated critical assessment of preliminary data and literature.
Well-defined, justified use of human subjects; compare with the value of similar studies in animals
Full consideration of human-subject issues in Application Form 398.
Consideration of any potential medical problems or side effects arising from the new procedures.
Appropriate and accurate methods for clinical and biological patient assessment; if methods utilized are somewhat simplistic and possibly unsophisticated, explain how the technology to be utilized is powerful enough to answer the questions posed.
Statistical Design Statistical methods should be appropriate for data to be collected
If possible and appropriate, consider randomized, double-blind prospective study designs.
Carefully estimate the incidence of the observed effect in normal or control populations
Show proper selection of control populations including matching for age, sex, race, color, clinical conditions, etc.
Provide the statistical rationale and methodology to determine the number of subjects required for each subject cohort; dropout and withdrawal must be considered; statistical power assumptions should be well defined
Typically, statistical consultants are required in the preparation of applications and the performance of studies; often, independent data units or centers are established to implement the study and allow the P.I. to remain unaware of patient assignment to treatment or control groups.
Patient Population Well defined, homogeneous subject population and control
Clearly defined entry criteria
Clearly defined exclusion criteria based on current or past diseases, utilization of specific medications, or the results of laboratory and clinical tests
Clearly defined recruitment procedures to be followed
Availability of a suitable patient population as well as any prior experience with that group of individuals.
Prior experience in recruiting and entering patients in a clinical study
Data Quality
Criteria for collecting, analyzing, and assessing clinical and laboratory data; define the accuracy of all data collected, including intra- and interoperator errors
Compliance monitoring
Monitoring procedural rigor for issues such as randomized and dosage modification
Monitoring by statistical unit (and P.I. where appropriate) for treatment benefits and side or toxic effects
Collaborative, multiinstitutional studies require special organizational structures to assure the uniformity of testing at each clinical unit
P.I. Qualifications and Experience
Strong qualifications as a biological and clinical investigator
Prior experience in clinical studies
Basic science skills may not translate to clinical studies
Common Misconceptions about the Review Process
The reviewers share your interest and enthusiasm in the proposal
The reviewers have expertise relevant to the subject of your proposal
All reviewers either have, or will make, time to read your proposal in detail
The reviewers will be fair and impartial in assessing the merits of your proposal
Specific Aims Section
IMPORTANT FACTS
One of the most important sections in the grant application and most difficult to write
One of the only sections that will be read by all of the reviewers of your application
It must quickly engender enthusiasm for your idea
The flow of logic must be compelling
Minimal Requirementsfor an Aims Sections
Brief introduction; knowns; unknowns; problem and why it is important to solve
Long-range goal
Objective of this application
Central hypothesis & how formulated
Rationale
Why you are best qualified (e.g., preliminary data, unique reagent, research environment)
Specific aims
Innovation, expectations and impact
Specific Aims Section
INTRODUCTORY PARAGRAPHBegins the flow of logic necessary to convert the reviewers to an advocate for your grant
Should open with what’s important to the mission of the funding agency
Should summarize the most important knowns that are related to the problem
Unknowns highlight gap in knowledge base
Conclude with why gap is a problem
Specific Aims Section
LONG-RANGE GOAL
This is not the goal of the current application
This is the goal of the overall program (of which the current application is a part)
Be realistic; do not overstate or overanticipate your capabilities
Specific Aims Section
OBJECTIVE OF THIS APPLICATION
Must be a step toward attainment of the long-term goal
Defines the purpose of the proposed research
Must be phrased in such a way that the central hypothesis clearly grows out of it.
Specific Aims Section
CENTRAL HYPOTHESIS
Make certain that you write a real hypothesis:“A tentative assumption made in order to draw out and test its logical or empirical consequences.”
Webster’s Dictionary
Most grant applications must be hypothesis-driven
Key Point
Tie the narrative for each of the aims together but avoid having feasibility of one aim dependent upon a particular outcome of another aim.
HYPOTHESIS: Components of automobile exhaust accelerate the degradation of statuary in Washington, D.C.
AIM 1: To determine the content of sulfur, lead and copper in statuary as a function of age.
AIM 2: To correlate improved condition of statuary with introduction of unleaded gasoline in the Washington, D.C. area.
Scope of Background
Describe what is known
Describe what is not known
Describe what needs to be done
Emphasize how your results will meet the stated need, i.e., solve problems that you have highlighted.
Preliminary Studies
Inadvisable to submit without some preliminary studies; the more the better
You must be able to convince the reviewer that you are not relying exclusively on the work of others.
Preliminary Studies
Published Studies: Describe first; include limited technical
date Include one or two figures/tables for each Provide reprints in the appendix
Unpublished Studies: Describe in more complete technical detail Acknowledge level of reliability
Approach to Budget forNIH Modular Applications
$25,000 direct cost increments up to $250,000
Provide budget justification for personnel (position, role, and percentage effort)
Include total cost estimate, not breakout, for consortium/contractual arrangements
Other support section provided “just-in-time”
Applications over $250,000/year must include detailed initial and subsequent year budget
Budget: Personnel
Expect personnel costs to be your highest
Ensure that you justify each person with respect to both effort and expertise
Percentage effort/salary can vary during the budget period; NSF limited to 2/9ths
“TBA” positions are the most vulnerable
Credibility can be lost, either by over-or underestimating needs (number & effort)
The Summary
Will be read by all reviewers
Must convey all of the application’s essential information
Must be written in plain English, because it will be used to summarize the agency’s investment
It must convey infectious enthusiasm for the project
In-House Review of Your Application
This is an absolute necessity!
Get review from knowledgeable colleagues
Give your colleagues time enough to help
Don’t ask for help while you are still making changes
Supplemental MaterialSubmitted After the Deadline
Correct an important error
Provide an important piece of missing information
Embellish your qualifications/publications
BUT REMEMBER
Supplementals are a hassle to the organizer of the review
Supplementals can irritate reviewers
Supplementals mailed close to the time of review may not be read
Grantsmanship Terminology GRANT:A funding award from the sponsor to an investigator, through his institution, to support designated work described in a written proposal. The sponsor generally has relatively little or no involvement in the work of the grant but does monitor performance. A grant is usually for a stipulated period of time or level of support. RFAs and R01s culminate in grants.
RFA“Request for application” Based on congressional mandates, NIH sets aside funds for particular public health topics and solicits grant proposals from the scientific community. The specific research question and methods are proposed by the investigator. NIH uses the RFA mechanism (over the RFP) if they feel more developmental work is needed, especially with respect to cost estimates.
Grantsmanship Terminology (cont’d) RFP:
“Request for proposal” NIH solicits proposals from the scientific community to accomplish a specific scope of work that is outlined in the RFP. Requirements are very specific and must be covered precisely by the applicant in his proposal. Both RFAs and RFPs are institute-initiated requests designed to stimulate research in areas designated by NIH advisory committees.
Study Section:A committee of external advisors to the NIH which carries out reviews of research applications in a general area of research, usually meeting regularly three times a calendar year for 2-3 days to perform these reviews. Study sections usually contain 12-25 regular members with ad hoc reviewers called when special expertise is needed.
Grantsmanship Terminology (cont’d)
Priority Score:The score assigned to a research application by a member of a study section that reflects that individual’s judgment regarding the scientific merit of the proposal. Also, the score assigned to the grant application as computed from the scores of individual reviewers.